Profile Summary :
Process Technologist is responsible to implement technology transfer process and technical support, to ensure it is in accordance with standard & procedure.
Responsibilities :
- Implement the Technology Transfer process and to ensure that robust reproducible and efficient manufacturing processes are transferred into Production from R&D, Contract manufacturers or other Reckitt Benckiser sites.
- Implement process validation, cleaning validation, and other related validation project
- Implement process development and improvement in the areas of cost, quality and customer service.
- Support the Global Manufacturing facilities providing technical support as required, working with the Regional Supply Technical Heads to support global manufacturing and engineering strategies.
- Review continuously manufacturing processes on the Cileungsi site and at contract manufacturers to determine the most cost effective supply strategy.
- Ensure that the company's strategic imperatives as they relate to the Technical Department are implemented.
- Perform management of projects within budgets and deadlines to ensure implementation of supply\technical strategy.
- Coordinate with cross functional project teams (Technology Transfer, Squeeze) to ensure business projects meet tight, often fixed deadlines.
- Establish self and/or team member follow GMP and other regulation related to safety and environment.
Qualification :
- At least 3 years experience working in a Process Development / R&D function in Healthcare, Pharmaceutical, or Medical Device related industry
- Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks
- Good understanding of regulatory and GMP requirements relevant to a regulated product e.g. EU GMP, WHO, PIC/S, CFR 21 Part 210/211
- Have a good knowledge and understanding on GMP (Good Manufacturing Practice), quality system, ISO 9001 : 28, hygienic plant design, validating abilities
- Strong interpersonal and communication skills
- Auditing skills, appropriate qualifications in auditing an advantage
- Language skills appropriate to the assigned country and/or regional cluster